Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

JOB SUMMARY

The CSV Validation Engineer II shall support CSV team in maintaining the systems/software in its most current validated state. Shall ensure that all required Software/System Development Lifecycle Documents are available. Shall be able to generate and execute validation documents including risk assessments, discrepancy management and reports; assist cross-functional team in identifying the required validation deliverables for new systems/software/equipment or changes to existing validated systems/software/equipment. Collaborate with departments inside the organization to maintain and improve computer system validation processes to ensure robust, efficient, and compliant processes. Have a good understanding and application of regulatory requirements - GxP, Annex 11, ICH Q7A, ASTM E2500 and GAMP

JOB DUTIES

• Assist cross-functional teams in completing system/equipment impact assessments, electronic record and electronic signature assessments.
• Author and review computer validation (IQ, OQ, and PQ) supporting GxP computerized systems, and relevant infrastructure, including system procurement, audit, performance, compliance evaluation, and validation.
• Perform all aspects of QMS (Quality Management System) processes (Change Control, Deviation, CAPA) as well as Validation Maintenance of computerized systems.
• Ensure appropriate regulatory requirements are addressed in the validation protocols.
• Execute validation/test protocols, follow good documentation practices, support discrepancy/deviations investigations and corrective action identification
• Author Reports and Trace Matrices for the computer/computerized systems.
• Perform gap assessments on vendor executed protocols, ensuring compliance is met and maintained.
• Support risk assessments and impact assessments following applicable SOPs.
• Provide guidance/support during specification (URS, FS, DDS or CS) document generation and review.
• Participate in the discrepancy/deviation review and closure.

• Excellent written and oral communication to include accurate and legible documentation skills.
• Ability to work in a fast-paced environment. Team oriented. Independent work skills and a strong work ethic.
• Microsoft Office and database management skills.

EXPERIENCE

• At least 3+ years of relevant computer systems validation systems/software/equipment supporting GMP manufacturing operation and laboratory equipment/instruments in a Pharmaceutical or CDMO industry.
• Knowledge of global regulations (e.g., FDA 21 CFR Part 11, EudraLex Volume 4 Annexure 11 etc.) and guidelines (e.g. FDA, MHRA Data integrity guidelines, etc.) around quality systems and computerized system validation in Biotech and/or Pharmaceutical industry a plus.

EDUCATION

• Bachelor's degree in Engineering, Computer Science in related discipline or equivalent.

QUALITIES

• Excellent written and oral communication to include accurate and legible documentation skills.
• Strong attention to detail. Understanding of group dynamics and teamwork
• Ability to execute industry best practices and implement these within the framework of existing GAMP regulations.

PHYSICAL REQUIREMENTS & MENTAL DEMANDS

• Must be able to sit or stand for prolonged periods of time
• Follows written instructions and can successfully manage multiple tasks

COMMUNICATIONS & CONTACTS

• Interacts with all departmental staff and other departments at all levels.

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Join us and be part of building the bridge between life changing therapies and patients.

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.